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Legislation Includes Whitehouse Provisions on Rare Diseases and Drug Safety

Tuesday, June 26, 2012

Washington, DC – The U.S. Senate today passed legislation to reauthorize the Food and Drug Administration’s (FDA) ability to approve prescription drugs, medical devices, and other medical products, sending the bill on to President Obama to sign into law. The final bill includes several important provisions authored or co-authored by U.S. Senator Sheldon Whitehouse (D-RI): a measure to expedite FDA’s approval process for innovative treatments for people with rare diseases; an amendment to help crack down on prescription drug abuse that endangers lives and drives up costs; and provisions to protect the safety of prescription drugs from counterfeits and dangerous overseas ingredients.

“This bill will benefit Rhode Island patients by taking steps to ensure that medications manufactured abroad are safe, speeding up the approval process for rare disease treatments, and supporting efforts to reduce prescription drug abuse,” said Whitehouse, a member of the Health, Education, Labor, and Pensions (HELP) Committee, which crafted the FDA legislation. “I was proud to work with my colleagues on both sides of the aisle on these provisions, and I’m glad we were able to win this victory for patients.”

A summary of the provisions authored or co-authored by Senator Whitehouse is below.

The Expanding and Promoting Expertise in Rare Treatments (EXPERT) Act (S. 2281): The FDA bill includes a provision based on a Whitehouse bill to foster the development of treatments for rare disease patients. It encourages the FDA to take advantage of the wisdom and insights of rare disease experts, in order to speed the development of new rare disease therapies. The bill also gives rare disease patients, and their advocates, a role in consulting with the FDA on topics like the severity of a rare disease, unmet medical need, and the benefits and risks of therapies to treat the disease.

The Interstate Drug Monitoring Efficiency and Data Sharing Act (S. 2254): The Senate also adopted an amendment based on legislation authored by Whitehouse and Senator Rob Portman (R-OH). The amendment authorizes the federal government to recommend measures to improve the interoperability of state prescription drug monitoring programs. It also requires the Department of Health and Human Services to submit a report to Congress on how to best enhance interoperability between state monitoring programs used for detecting and reducing fraud, diversion, and abuse of prescription drugs. The report is expected to advance the development of health information technologies that will help patients, physicians, and pharmacies cut down on dangerous and costly prescription drug abuse.

Drug Supply Chain Integrity: The legislation includes a series of provisions developed by Whitehouse and Senators Tom Harkin (D-IA), Mike Enzi (R-WY), Michael Bennet (D-CO), Richard Burr (R-NC), and Chuck Grassley (R-IA) to better secure medications from tainted or counterfeit ingredients manufactured overseas. The measure would strengthen inspections of overseas prescription drug manufacturing facilities; allow the FDA to ask drug manufacturing facilities to electronically submit information to expedite the inspection process; and require the FDA to develop its inspection schedule based on risk, so that higher-risk facilities are inspected more often regardless of their location. It would also allow the FDA to refuse admission of a drug made at a firm that delayed or refused an FDA inspection, and enhance penalties for individuals who intentionally adulterate and/or counterfeit drugs. Finally, the measure creates higher standards for manufacturer quality control and admission of drugs to the U.S.

The overall FDA reauthorization package is expected to help address the growing problem of drug shortages in the U.S. – an issue Senator Whitehouse has worked on with Senator Grassley. The two Senators have asked the Government Accountability Office to study to what extent the Drug Enforcement Administration’s attempts to curb dangerous controlled substances inadvertently contribute to shortages of prescription medications.